Question

You are on the DSMB of a double-blind clinical trial of a two-arm pharmaceutical intervention study with a time-to-event outcome. A DSMB meeting will occur after the first third of the participants are enrolled. Briefly describe two data summaries you would expect to be reported on in the closed session of a DSMB meeting (summaries that would not also be included in the open session), and give a brief rationale for why the DSMB would want to see those summaries.

Answer 1

Two data summaries you would expect to be reported on in the closed session of a DSMB meeting are:

1. Summary of the research protocol and plans that is used for data and safety monitoring.

This summary should be confidential as it include protocol that is used in the monitoring of the safety of the individual. DSMB have a right to recommend the changes in protocol in order to bring the safety of individual.

2. Summary of the outcome result of toxicity data

This summary should remain confidential as to decide whether the study should continue in the original way or it has to be changed, or be terminated